Pfizer's Xeljanz, Bayer's Stivarga lead Japanese approvals

The Japanese Ministry of Health, Labor and Welfare (MHLW) has issued approvals for a batch of new drugs including Pfizer's rheumatoid arthritis pill Xeljanz (tofacitinib citrate) and Bayer's Stivarga (regorafenib) for advanced/recurrent colorectal cancer (CRC).

Specifically, Pfizer's Xeljanz - the first approved pill in a new class of medicines called Janus kinase (JAK) inhibitors - has been given the go-ahead for the treatment of adults with RA who have failed to respond to existing therapies.

The approval comes on the back of a global clinical development programme including 5,000 patients, which found that Xeljanz 5mg twice daily was effective when administered alone or when given in combination with a non-biologic DMARD, such as methotrexate, in patients unresponsive to non-biologic or biologic DMARDs, including tumour necrosis factor (TNF) inhibitors.

Xeljanz - which received a US green light in November last year - will be commercially available in Japan after the National Health Insurance listing, and will be co-promoted in the country by Pfizer and Takeda.

RA affects 700,000 – 800,000 people in Japan. Up to one-third of these fail to respond to standard therapies, and about half stop using a particular disease-modifying treatment within five years, Pfizer noted, highlighting the need for new treatment options.

Elsewhere, Bayer's Stivarga has been approved for the treatment of patients with unresectable, advanced/recurrent CRC, after data from the pivotal Phase III CORRECT study showed a statistically significant improvement in overall survival and progression-free survival compared to placebo in patients whose disease had progressed despite prior treatment.

"The incidence of colorectal cancer is increasing in Japan and we are limited in the number of treatment options available to patients with advanced disease," said Takayuki Yoshino, Chief of Department of Gastroenterology and Gastrointestinal Oncology at the National Cancer Center Hospital East, Japan, noting that Stivarga has been shown to "prolong overall survival and slow the progression of cancer and provides an important treatment advance for patients with mCRC who have no further treatment options."

Boxed warning

Stivarga - an oral multi-kinase inhibitor that targeting the mechanisms involved in tumour growth and progression - won US backing in September, with a boxed warning that severe and fatal liver toxicity occurred in patients treated with the drug during clinical studies.

Meantime, GlaxoSmithKline and Genmab also announced the approval of Arzerra (ofatumumab) by the MHLW for use in patients with relapsed/refractory CD20-positive chronic lymphocytic leukaemia. The thumbs-up triggers a milestone payment of 20 million Danish kroner to Genmab.

The agency also approved Eisai's Inovelon (rufinamide) as an adjunctive therapy to other antiepileptic drugs in the treatment of Lennox-Gastaut syndrome and Nippon Shinyaku Co's Regtect (acamprosate) for support maintenance of abstinence in patients with alcohol dependence.